Form 483

Wells Pharma of Houston LLC Form 483, 2021-06-17

FDA issued a Form 483 to Wells Pharma of Houston LLC on 2021-06-17 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Wells Pharma of Houston LLC · Houston, United States · Issued June 17, 2021

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Jun 2021
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Stephen D Brown

Inspected site

WPWells Pharma of Houston LLCHouston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x

Full 483 report

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  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere